A Dose Ranging Study of the Effect of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation
ClinicalTrials.gov Identifier:
NCT00778700
First received: October 21, 2008
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

The study will be a double-blind, randomized, vehicle-controlled study with application of INCB018424 phosphate cream or vehicle in patients with stable plaque psoriasis. Application will be QD for 12 weeks without occlusive dressings. There will be 4 treatments of 50 subjects each.


Condition Intervention Phase
Plaque Psoriasis
Drug: INCB018424 Phosphate Cream
Drug: Placebo Cream
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Vehicle-Controlled Dose Ranging Study of the Effect of INCB018424 Phosphate Cream When Applied to Patients With Plaque Psoriasis

Resource links provided by NLM:


Further study details as provided by Incyte Corporation:

Primary Outcome Measures:
  • Absolute change from Baseline to Day 84 in total lesion score for all treatable psoriatic lesions. [ Time Frame: Baseline and Day 84 (or early study termination visit) ] [ Designated as safety issue: No ]
    Sum of erythema, scaling, and thickness for all treatable lesions


Secondary Outcome Measures:
  • Percentage of subjects achieving none (score=0) and mild (score=1) in each of the individual lesion scores at Day 84 [ Time Frame: Baseline and Day 84 ] [ Designated as safety issue: No ]
    Lesion scores of 0 or 1


Enrollment: 199
Study Start Date: October 2008
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment 1: INCB018424
INCB018424 -- 0.5 percent phosphate cream
Drug: INCB018424 Phosphate Cream
0.5, 1.0 and 1.5% phosphate cream
Experimental: Treatment 2: INCB018424
INCB018424 -- 1.0 percent phosphate cream
Drug: INCB018424 Phosphate Cream
0.5, 1.0 and 1.5% phosphate cream
Experimental: Treatment 3: INCB018424
INCB018424 -- 1.5 percent phosphate cream
Drug: INCB018424 Phosphate Cream
0.5, 1.0 and 1.5% phosphate cream
Placebo Comparator: Treatment 4: Placebo
Placebo cream
Drug: Placebo Cream
Cream with no active drug

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Plaque psoriasis involving up to 2 to 20% Body Surface Area

Exclusion Criteria:

  • Lesions solely involving intertriginious areas, the scalp or the face
  • Systemic therapy for their psoriasis
  • Pustular psoriasis or erythroderma
  • Currently on other topical agents or UVB therapy within 2 weeks of the first dose of study medication
  • Started or discontinued therapy within 2 months of Screening with agents that can exacerbate psoriasis
  • Receiving systemic triazole antifungals except fluconazole
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00778700

  Show 28 Study Locations
Sponsors and Collaborators
Incyte Corporation
Investigators
Study Director: Monica Luchi, M.D. Incyte Corporation
  More Information

No publications provided

Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT00778700     History of Changes
Other Study ID Numbers: INCB 18424-203
Study First Received: October 21, 2008
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on April 17, 2014